Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study

NCT07094529 | Recruiting

• 1 other identifier: 20250297-01H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will offer two study interventions designed to bring on a mild low blood sugar (capillary blood glucose result 3.0 to 3.8 mmol/L), in order to study the effectiveness of each study participant's personal choice of treatment and first recheck time. The two study interventions that the participant can choose to complete (one or both interventions). Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities, and choose one of 4 capillary blood glucose recheck times.

Conditions

Type 2 Diabetes (T2DM); Hypoglycemia (Diabetic)

Keywords

hypoglycemia

Outcome Measures

Primary Outcomes (1)

• To determine feasibility to recruit an average of 8 patients per month at the study site (The Ottawa Hospital Diabetes clinics) for study protocol performance.

  Average number of patients recruited per month is determined by 60 patients (the target recruitment number) for each study intervention, divided by the number of months that it took to complete the recruitment.

  12 months

Secondary Outcomes (1)

• To assess the percentage hypoglycemia resolution for people living with type 2 diabetes based on their personalized choice of treatment and first recheck time.

  12 months

Study Arms (2)

Recumbent Exercise Bike to induce mild hypoglycemia

EXPERIMENTAL

The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia.

Behavioral: Recumbent Exercise Bike to induce mild hypoglycemia

Delaying food to induce mild hypoglycemia

EXPERIMENTAL

At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol.

Behavioral: Delaying food to induce mild hypoglycemia,

Interventions

Recumbent Exercise Bike to induce mild hypoglycemia BEHAVIORAL

The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia, determined by capillary blood glucose test result 3.0 to 3.8 mmmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.

Recumbent Exercise Bike to induce mild hypoglycemia

Delaying food to induce mild hypoglycemia, BEHAVIORAL

At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol. No food intake (water is allowed) until there is onset of mild hypoglycemia, determined by a capillary blood glucose test result 3.0 to 3.8 mmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.

Delaying food to induce mild hypoglycemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Consent provided
• Age \>= 18 years.
• Diagnosed as type 2 diabetes mellitus.
• Type 2 diabetes medications include at least one of the following for at least one month prior to entering the study: sulfonylurea or insulin of any type.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Diagnosed as another form of diabetes mellitus.
• Has a history of hypoglycemia unawareness.
• Had a hypoglycemia event, defined as capillary blood glucose \< 3.9 mmol/L within 24 hours prior to the study visit booking time.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cathy Sun, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Sun, MD MSc

CONTACT

613-738-8333; csun@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)